Robotic-assisted Training After Upper Arm Fracture (RASTA)

Robotic-assisted Training After Upper Arm Fracture - a Multicentre, Controlled and Randomized Intervention Study

Berufsgenossenschaftliche Unfallklinik Murnau, Berufsgenossenschaftliche Unfallklinik Ludwigshafen, Deutsche Gesetzliche Unfallversicherung (DGUV)

In this study, patients with upper arm fracture will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks on the injured arm in addition to conventional physio- and occupational therapy. The supportive treatment and execution of specific exercises on the Armeo®Spring should lead to improved recovery of function and mobility of the upper arm compared to conservatively treated patients.

60 Patients aged between 35 and 70 years with proximal humeral fracture and surgical treatment will be recruited in three different clinics in Germany and randomised into an intervention and a control group. Participants will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. Baseline assessment will assess cognition (SOMC), level of pain in the affected arm, ability to work, gait speed (10m walk), disability of the arm, shoulder and hand (DASH), as well as the range of motion of the affected arm (goniometer measurement), visual acuity and motor function of orthopaedic patients (WMFT-O). Clinical follow up directly after intervention will assess disability of the arm, shoulder and hand (DASH), the range of motion and motor function (WMFT-O). Primary outcome parameter will be the DASH and secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by a postal follow-up. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.

Patients will be recruited in three different clinics in Germany and randomised into an intervention and a control group. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.

The intervention group will receive conventional occupational- and physiotherapy and an additive robotic-assisted training using the Armeo®Spring robot for three weeks.

The robotic-assisted training will be performed using the clinically evaluated Armeo®Spring medical device (Hocoma AG, Zurich, Switzerland). By means of a sensory orthosis, arm movements will be supported and transmitted to a computer system and visually shown on a screen.

DASH will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months for assessing the change

WMFT will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change

ROM will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change

grip strength will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change

Inclusion Criteria: surgical treatment of the shoulder joint after upper arm fracture classified as type AO 11 movement-stable fracture Inclusion between the fourth and the seventh week after surgery Exclusion Criteria: limited cognition as defined by a score in Short-Orientation-Memory-Concentration Test (SOMC) less than 10 points inadequate level of pain during movement of the affected shoulder joint (pain score >5 on a visual analogue pain scale) strongly limited vision or hearing heart failure (New York Heart Association stage III-IV) or COPD (Chronic Obstructive Pulmonary Disease) Gold stage III-IV walking speed <0.8m/sec isolated tuberculum majus fracture of the humerus (AO 11, A1) fractures with involvement of the glenoid cavity double fractures injury of the plexus or the axillaris nerve

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Nerz C, Schwickert L, Scholch S, Gordt K, Nolte PC, Kroger I, Augat P, Becker C. Inter-rater reliability, sensitivity to change and responsiveness of the orthopaedic Wolf-Motor-Function-Test as functional capacity measure before and after rehabilitation in patients with proximal humeral fractures. BMC Musculoskelet Disord. 2019 Jul 6;20(1):315. doi: 10.1186/s12891-019-2691-0.

Nerz C, Schwickert L, Becker C, Studier-Fischer S, Mussig JA, Augat P. Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a randomised, controlled, multicentre trial. Trials. 2017 Dec 6;18(1):589. doi: 10.1186/s13063-017-2274-z.